A Study to Determine the Pharmacokinetics of Cediranib in Chinese Patients With Advanced Solid Malignancies

AstraZeneca

Status and phase

Completed

Phase 1

Conditions

Advanced Solid Malignancies

Treatments

Drug: cediranib (RECENTIN TM, AZD2171)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00981721

D8480C00060

Details and patient eligibility

About

This study is being carried out to see how single and multiple doses of cediranib are handled by the body (that is how they are absorbed, broken down and got rid of from the body) by measuring levels of drug in the blood in Chinese patients with advanced solid malignancies.

The study will also assess the tolerability of 20 or 30 mg cediranib in Chinese patients and how the tumour responds to treatment with cediranib.

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Provision of informed consent
Histological and/or cytological confirmed advanced solid malignancies
Refractory to conventional therapeutic modalities, or for which no appropriate therapies exist

Exclusion criteria

For the first question: Patients with a history of poorly controlled hypertension with resting blood pressure >150/100 mmHg in the presence or absence of a stable regimen of antihypertensive therapy, or patients who are requiring maximal doses of calcium channel blockers to stabilize blood pressure.
Significant haemorrhage (>30 ml/bleeding episode in previous 3 months), haemoptysis (>5 ml fresh blood in previous 4 weeks) or thrombotic event (including transient ischaemic attack) in the previous 12 months
Recent(<28 days) major thoracic and abdominal surgery prior to entry into the study, or a surgical incision that is not fully healed.